§ 136a-1. — Reregistration of registered pesticides.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 7USC136a-1]
TITLE 7--AGRICULTURE
CHAPTER 6--INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL
SUBCHAPTER II--ENVIRONMENTAL PESTICIDE CONTROL
Sec. 136a-1. Reregistration of registered pesticides
(a) General rule
The Administrator shall reregister, in accordance with this section,
each registered pesticide containing any active ingredient contained in
any pesticide first registered before November 1, 1984, except for any
pesticide as to which the Administrator has determined, after November
1, 1984, and before the effective date of this section, that--
(1) there are no outstanding data requirements; and
(2) the requirements of section 136a(c)(5) of this title have
been satisfied.
(b) Reregistration phases
Reregistrations of pesticides under this section shall be carried
out in the following phases:
(1) The first phase shall include the listing under subsection
(c) of this section of the active ingredients of the pesticides that
will be reregistered.
(2) The second phase shall include the submission to the
Administrator under subsection (d) of this section of notices by
registrants respecting their intention to seek reregistration,
identification by registrants of missing and inadequate data for
such pesticides, and commitments by registrants to replace such
missing or inadequate data within the applicable time period.
(3) The third phase shall include submission to the
Administrator by registrants of the information required under
subsection (e) of this section.
(4) The fourth phase shall include an independent, initial
review by the Administrator under subsection (f) of this section of
submissions under phases two and three, identification of
outstanding data requirements, and the issuance, as necessary, of
requests for additional data.
(5) The fifth phase shall include the review by the
Administrator under subsection (g) of this section of data submitted
for reregistration and appropriate regulatory action by the
Administrator.
(c) Phase one
(1) Priority for reregistration
For purposes of the reregistration of the pesticides described
in subsection (a) of this section, the Administrator shall list the
active ingredients of pesticides and shall give priority to, among
others, active ingredients (other than active ingredients for which
registration standards have been issued before the effective date of
this section) that--
(A) are in use on or in food or feed and may result in
postharvest residues;
(B) may result in residues of potential toxicological
concern in potable ground water, edible fish, or shellfish;
(C) have been determined by the Administrator before the
effective date of this section to have significant outstanding
data requirements; or
(D) are used on crops, including in greenhouses and
nurseries, where worker exposure is most likely to occur.
(2) Reregistration lists
For purposes of reregistration under this section, the
Administrator shall by order--
(A) not later than 70 days after the effective date of this
section, list pesticide active ingredients for which
registration standards have been issued before such effective
date;
(B) not later than 4 months after such effective date, list
the first 150 pesticide active ingredients, as determined under
paragraph (1);
(C) not later than 7 months after such effective date, list
the second 150 pesticide active ingredients, as determined under
paragraph (1); and
(D) not later than 10 months after such effective date, list
the remainder of the pesticide active ingredients, as determined
under paragraph (1).
Each list shall be published in the Federal Register.
(3) Judicial review
The content of a list issued by the Administrator under
paragraph (2) shall not be subject to judicial review.
(4) Notice to registrants
On the publication of a list of pesticide active ingredients
under paragraph (2), the Administrator shall send by certified mail
to the registrants of the pesticides containing such active
ingredients a notice of the time by which the registrants are to
notify the Administrator under subsection (d) of this section
whether the registrants intend to seek or not to seek reregistration
of such pesticides.
(d) Phase two
(1) In general
The registrant of a pesticide that contains an active ingredient
listed under subparagraph (B), (C), or (D) of subsection (c)(2) of
this section shall submit to the Administrator, within the time
period prescribed by paragraph (4), the notice described in
paragraph (2) and any information, commitment, or offer described in
paragraph (3).
(2) Notice of intent to seek or not to seek reregistration
(A) The registrant of a pesticide containing an active
ingredient listed under subparagraph (B), (C), or (D) of subsection
(c)(2) of this section shall notify the Administrator by certified
mail whether the registrant intends to seek or does not intend to
seek reregistration of the pesticide.
(B) If a registrant submits a notice under subparagraph (A) of
an intention not to seek reregistration of a pesticide, the
Administrator shall publish a notice in the Federal Register stating
that such a notice has been submitted.
(3) Missing or inadequate data
Each registrant of a pesticide that contains an active
ingredient listed under subparagraph (B), (C), or (D) of subsection
(c)(2) of this section and for which the registrant submitted a
notice under paragraph (2) of an intention to seek reregistration of
such pesticide shall submit to the Administrator--
(A) in accordance with regulations issued by the
Administrator under section 136a of this title, an
identification of--
(i) all data that are required by regulation to support
the registration of the pesticide with respect to such
active ingredient;
(ii) data that were submitted by the registrant
previously in support of the registration of the pesticide
that are inadequate to meet such regulations; and
(iii) data identified under clause (i) that have not
been submitted to the Administrator; and
(B) either--
(i) a commitment to replace the data identified under
subparagraph (A)(ii) and submit the data identified under
subparagraph (A)(iii) within the applicable time period
prescribed by paragraph (4)(B); or
(ii) an offer to share in the cost to be incurred by a
person who has made a commitment under clause (i) to replace
or submit the data and an offer to submit to arbitration as
described by section 136a(c)(2)(B) of this title with regard
to such cost sharing.
For purposes of a submission by a registrant under subparagraph
(A)(ii), data are inadequate if the data are derived from a study
with respect to which the registrant is unable to make the
certification prescribed by subsection (e)(1)(G) of this section
that the registrant possesses or has access to the raw data used in
or generated by such study. For purposes of a submission by a
registrant under such subparagraph, data shall be considered to be
inadequate if the data are derived from a study submitted before
January 1, 1970, unless it is demonstrated to the satisfaction of
the Administrator that such data should be considered to support the
registration of the pesticide that is to be reregistered.
(4) Time periods
(A) A submission under paragraph (2) or (3) shall be made--
(i) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(B) of this section,
not later than 3 months after the date of publication of the
listing of such active ingredient;
(ii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(C) of this section,
not later than 3 months after the date of publication of the
listing of such active ingredient; and
(iii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(D) of this section,
not later than 3 months after the date of publication of the
listing of such active ingredient.
On application, the Administrator may extend a time period
prescribed by this subparagraph if the Administrator determines that
factors beyond the control of the registrant prevent the registrant
from complying with such period.
(B) A registrant shall submit data in accordance with a
commitment entered into under paragraph (3)(B) within a reasonable
period of time, as determined by the Administrator, but not more
than 48 months after the date the registrant submitted the
commitment. The Administrator, on application of a registrant, may
extend the period prescribed by the preceding sentence by no more
than 2 years if extraordinary circumstances beyond the control of
the registrant prevent the registrant from submitting data within
such prescribed period. Upon application of a registrant, the
Administrator shall, in the case of a minor use, extend the deadline
for the production of residue chemistry data under this subparagraph
for data required solely to support that minor use until the final
deadline for submission of data under this section for the other
uses of the pesticide established as of August 3, 1996, if--
(i) the data to support other uses of the pesticide on a
food are being provided;
(ii) the registrant, in submitting a request for such an
extension provides a schedule, including interim dates to
measure progress, to assure that the data production will be
completed before the expiration of the extension period;
(iii) the Administrator has determined that such extension
will not significantly delay the Administrator's schedule for
issuing a reregistration eligibility determination required
under this section; and
(iv) the Administrator has determined that based on existing
data, such extension would not significantly increase the risk
of any unreasonable adverse effect on the environment. If the
Administrator grants an extension under this subparagraph, the
Administrator shall monitor the development of the data and
shall ensure that the registrant is meeting the schedule for the
production of the data. If the Administrator determines that the
registrant is not meeting or has not met the schedule for the
production of such data, the Administrator may proceed in
accordance with clause (iv) of section 136a(c)(2)(B) of this
title or other provisions of this section, as appropriate,
regarding the continued registration of the affected products
with the minor use and shall inform the public of such action.
Notwithstanding the provisions of this subparagraph, the
Administrator may take action to modify or revoke the extension
under this subparagraph if the Administrator determines that the
extension for the minor use may cause an unreasonable adverse
effect on the environment. In such circumstance, the
Administrator shall provide written notice to the registrant
revoking the extension of time for submission of data. Such data
shall instead be due in accordance with the date then
established by the Administrator for submission of the data.
(5) Cancellation and removal
(A) If the registrant of a pesticide does not submit a notice
under paragraph (2) or (3) within the time prescribed by paragraph
(4)(A), the Administrator shall issue a notice of intent to cancel
the registration of such registrant for such pesticide and shall
publish the notice in the Federal Register and allow 60 days for the
submission of comments on the notice. On expiration of such 60 days,
the Administrator, by order and without a hearing, may cancel the
registration or take such other action, including extension of
applicable time periods, as may be necessary to enable
reregistration of such pesticide by another person.
(B)(i) If--
(I) no registrant of a pesticide containing an active
ingredient listed under subsection (c)(2) of this section
notifies the Administrator under paragraph (2) that the
registrant intends to seek reregistration of any pesticide
containing that active ingredient;
(II) no such registrant complies with paragraph (3)(A); or
(III) no such registrant makes a commitment under paragraph
(3)(B) to replace or submit all data described in clauses (ii)
and (iii) of paragraph (3)(A);
the Administrator shall publish in the Federal Register a notice of
intent to remove the active ingredient from the list established
under subsection (c)(2) of this section and a notice of intent to
cancel the registrations of all pesticides containing such active
ingredient and shall provide 60 days for comment on such notice.
(ii) After the 60-day period has expired, the Administrator, by
order, may cancel any such registration without hearing, except that
the Administrator shall not cancel a registration under this
subparagraph if--
(I) during the comment period a person acquires the rights
of the registrant in that registration;
(II) during the comment period that person furnishes a
notice of intent to reregister the pesticide in accordance with
paragraph (2); and
(III) not later than 120 days after the publication of the
notice under this subparagraph, that person has complied with
paragraph (3) and the fee prescribed by subsection (i)(1) of
this section has been paid.
(6) Suspensions and penalties
The Administrator shall issue a notice of intent to suspend the
registration of a pesticide in accordance with the procedures
prescribed by section 136a(c)(2)(B)(iv) of this title if the
Administrator determines that (A) progress is insufficient to ensure
the submission of the data required for such pesticide under a
commitment made under paragraph (3)(B) within the time period
prescribed by paragraph (4)(B) or (B) the registrant has not
submitted such data to the Administrator within such time period. If
the registrant does not commit to support a specific minor use of
the pesticide, but is supporting and providing data in a timely and
adequate fashion to support uses of the pesticide on a food, or if
all uses of the pesticide are nonfood uses and the registrant does
not commit to support a specific minor use of the pesticide but is
supporting and providing data in a timely and adequate fashion to
support other nonfood uses of the pesticide, the Administrator, at
the written request of the registrant, shall not take any action
pursuant to this paragraph in regard to such unsupported minor use
until the final deadline established as of August 3, 1996, for the
submission of data under this section for the supported uses
identified pursuant to this paragraph unless the Administrator
determines that the absence of the data is significant enough to
cause human health or environmental concerns. On such a
determination the Administrator may refuse the request for extension
by the registrant. Upon receipt of the request from the registrant,
the Administrator shall publish in the Federal Register a notice of
the receipt of the request and the effective date upon which the
uses not being supported will be voluntarily deleted from the
registration pursuant to section 136d(f)(1) of this title. If the
Administrator grants an extension under this paragraph, the
Administrator shall monitor the development of the data for the uses
being supported and shall ensure that the registrant is meeting the
schedule for the production of such data. If the Administrator
determines that the registrant is not meeting or has not met the
schedule for the production of such data, the Administrator may
proceed in accordance with section 136a(c)(2)(B)(iv) of this title
regarding the continued registration of the affected products with
the minor and other uses and shall inform the public of such action
in accordance with section 136d(f)(2) of this title. Notwithstanding
this subparagraph, the Administrator may deny, modify, or revoke the
temporary extension under this paragraph if the Administrator
determines that the continuation of the minor use may cause an
unreasonable adverse effect on the environment. In the event of
modification or revocation, the Administrator shall provide, in
writing, to the registrant a notice revoking the temporary extension
and establish a new effective date by which the minor use shall be
deleted from the registration.
(e) Phase three
(1) Information about studies
Each registrant of a pesticide that contains an active
ingredient listed under subparagraph (B), (C), or (D) of subsection
(c)(2) of this section who has submitted a notice under subsection
(d)(2) of this section of an intent to seek the reregistration of
such pesticide shall submit, in accordance with the guidelines
issued under paragraph (4), to the Administrator--
(A) a summary of each study concerning the active ingredient
previously submitted by the registrant in support of the
registration of a pesticide containing such active ingredient
and considered by the registrant to be adequate to meet the
requirements of section 136a of this title and the regulations
issued under such section;
(B) a summary of each study concerning the active ingredient
previously submitted by the registrant in support of the
registration of a pesticide containing such active ingredient
that may not comply with the requirements of section 136a of
this title and the regulations issued under such section but
which the registrant asserts should be deemed to comply with
such requirements and regulations;
(C) a reformat of the data from each study summarized under
subparagraph (A) or (B) by the registrant concerning chronic
dosing, oncogenicity, reproductive effects, mutagenicity,
neurotoxicity, teratogenicity, or residue chemistry of the
active ingredient that were submitted to the Administrator
before January 1, 1982;
(D) where data described in subparagraph (C) are not
required for the active ingredient by regulations issued under
section 136a of this title, a reformat of acute and subchronic
dosing data submitted by the registrant to the Administrator
before January 1, 1982, that the registrant considers to be
adequate to meet the requirements of section 136a of this title
and the regulations issued under such section;
(E) an identification of data that are required to be
submitted to the Administrator under section 136d(a)(2) of this
title, indicating an adverse effect of the pesticide;
(F) an identification of any other information available
that in the view of the registrant supports the registration;
(G) a certification that the registrant or the Administrator
possesses or has access to the raw data used in or generated by
the studies that the registrant summarized under subparagraph
(A) or (B);
(H) either--
(i) a commitment to submit data to fill each outstanding
data requirement identified by the registrant; or
(ii) an offer to share in the cost of developing such
data to be incurred by a person who has made a commitment
under clause (i) to submit such data, and an offer to submit
to arbitration as described by section 136a(c)(2)(B) of this
title with regard to such cost sharing; and
(I) evidence of compliance with section 136a(c)(1)(D)(ii)
\1\ of this title and regulations issued thereunder with regard
to previously submitted data as if the registrant were now
seeking the original registration of the pesticide.
---------------------------------------------------------------------------
\1\ See References in Text note below.
A registrant who submits a certification under subparagraph (G) that
is false shall be considered to have violated this subchapter and
shall be subject to the penalties prescribed by section 136l of this
title.
(2) Time periods
(A) The information required by paragraph (1) shall be submitted
to the Administrator--
(i) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(B) of this section,
not later than 12 months after the date of publication of the
listing of such active ingredient;
(ii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(C) of this section,
not later than 12 months after the date of publication of the
listing of such active ingredient; and
(iii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(D) of this section,
not later than 12 months after the date of publication of the
listing of such active ingredient.
(B) A registrant shall submit data in accordance with a
commitment entered into under paragraph (1)(H) within a reasonable
period of time, as determined by the Administrator, but not more
than 48 months after the date the registrant submitted the
commitment under such paragraph. The Administrator, on application
of a registrant, may extend the period prescribed by the preceding
sentence by no more than 2 years if extraordinary circumstances
beyond the control of the registrant prevent the registrant from
submitting data within such prescribed period. Upon application of a
registrant, the Administrator shall, in the case of a minor use,
extend the deadline for the production of residue chemistry data
under this subparagraph for data required solely to support that
minor use until the final deadline for submission of data under this
section for the other uses of the pesticide established as of August
3, 1996, if--
(i) the data to support other uses of the pesticide on a
food are being provided;
(ii) the registrant, in submitting a request for such an
extension provides a schedule, including interim dates to
measure progress, to assure that the data production will be
completed before the expiration of the extension period;
(iii) the Administrator has determined that such extension
will not significantly delay the Administrator's schedule for
issuing a reregistration eligibility determination required
under this section; and
(iv) the Administrator has determined that based on existing
data, such extension would not significantly increase the risk
of any unreasonable adverse effect on the environment. If the
Administrator grants an extension under this subparagraph, the
Administrator shall monitor the development of the data and
shall ensure that the registrant is meeting the schedule for the
production of the data. If the Administrator determines that the
registrant is not meeting or has not met the schedule for the
production of such data, the Administrator may proceed in
accordance with clause (iv) of section 136a(c)(2)(B) of this
title or other provisions of this section, as appropriate,
regarding the continued registration of the affected products
with the minor use and shall inform the public of such action.
Notwithstanding the provisions of this subparagraph, the
Administrator may take action to modify or revoke the extension
under this subparagraph if the Administrator determines that the
extension for the minor use may cause an unreasonable adverse
effect on the environment. In such circumstance, the
Administrator shall provide written notice to the registrant
revoking the extension of time for submission of data. Such data
shall instead be due in accordance with the date then
established by the Administrator for submission of the data.
(3) Cancellation
(A) If the registrant of a pesticide fails to submit the
information required by paragraph (1) within the time prescribed by
paragraph (2), the Administrator, by order and without hearing,
shall cancel the registration of such pesticide. If the registrant
does not commit to support a specific minor use of the pesticide,
but is supporting and providing data in a timely and adequate
fashion to support uses of the pesticide on a food, or if all uses
of the pesticide are nonfood uses and the registrant does not commit
to support a specific minor use of the pesticide but is supporting
and providing data in a timely and adequate fashion to support other
nonfood uses of the pesticide, the Administrator, at the written
request of the registrant, shall not take any action pursuant to
this subparagraph in regard to such unsupported minor use until the
final deadline established as of August 3, 1996, for the submission
of data under this section for the supported uses identified
pursuant to this subparagraph unless the Administrator determines
that the absence of the data is significant enough to cause human
health or environmental concerns. On the basis of such
determination, the Administrator may refuse the request for
extension by the registrant. Upon receipt of the request from the
registrant, the Administrator shall publish in the Federal Register
a notice of the receipt of the request and the effective date upon
which the uses not being supported will be voluntarily deleted from
the registration pursuant to section 136d(f)(1) of this title. If
the Administrator grants an extension under this subparagraph, the
Administrator shall monitor the development of the data for the uses
being supported and shall ensure that the registrant is meeting the
schedule for the production of such data. If the Administrator
determines that the registrant is not meeting or has not met the
schedule for the production of such data, the Administrator may
proceed in accordance with section 136a(c)(2)(B)(iv) of this title
regarding the continued registration of the affected products with
the minor and other uses and shall inform the public of such action
in accordance with section 136d(f)(2) of this title. Notwithstanding
this subparagraph, the Administrator may deny, modify, or revoke the
temporary extension under this subparagraph if the Administrator
determines that the continuation of the minor use may cause an
unreasonable adverse effect on the environment. In the event of
modification or revocation, the Administrator shall provide, in
writing, to the registrant a notice revoking the temporary extension
and establish a new effective date by which the minor use shall be
deleted from the registration.
(B)(i) If the registrant of a pesticide submits the information
required by paragraph (1) within the time prescribed by paragraph
(2) and such information does not conform to the guidelines for
submissions established by the Administrator, the Administrator
shall determine whether the registrant made a good faith attempt to
conform its submission to such guidelines.
(ii) If the Administrator determines that the registrant made a
good faith attempt to conform its submission to such guidelines, the
Administrator shall provide the registrant a reasonable period of
time to make any necessary changes or corrections.
(iii)(I) If the Administrator determines that the registrant did
not make a good faith attempt to conform its submission to such
guidelines, the Administrator may issue a notice of intent to cancel
the registration. Such a notice shall be sent to the registrant by
certified mail.
(II) The registration shall be canceled without a hearing or
further notice at the end of 30 days after receipt by the registrant
of the notice unless during that time a request for a hearing is
made by the registrant.
(III) If a hearing is requested, a hearing shall be conducted
under section 136d(d) of this title, except that the only matter for
resolution at the hearing shall be whether the registrant made a
good faith attempt to conform its submission to such guidelines. The
hearing shall be held and a determination made within 75 days after
receipt of a request for hearing.
(4) Guidelines
(A) Not later than 1 year after the effective date of this
section, the Administrator, by order, shall issue guidelines to be
followed by registrants in--
(i) summarizing studies;
(ii) reformatting studies;
(iii) identifying adverse information; and
(iv) identifying studies that have been submitted previously
that may not meet the requirements of section 136a of this title
or regulations issued under such section,
under paragraph (1).
(B) Guidelines issued under subparagraph (A) shall not be
subject to judicial review.
(5) Monitoring
The Administrator shall monitor the progress of registrants in
acquiring and submitting the data required under paragraph (1).
(f) Phase four
(1) Independent review and identification of outstanding
data requirements
(A) The Administrator shall review the submissions of all
registrants of pesticides containing a particular active ingredient
under subsections (d)(3) and (e)(1) of this section to determine if
such submissions identified all the data that are missing or
inadequate for such active ingredient. To assist the review of the
Administrator under this subparagraph, the Administrator may require
a registrant seeking reregistration to submit complete copies of
studies summarized under subsection (e)(1) of this section.
(B) The Administrator shall independently identify and publish
in the Federal Register the outstanding data requirements for each
active ingredient that is listed under subparagraph (B), (C), or (D)
of subsection (c)(2) of this section and that is contained in a
pesticide to be reregistered under this section. The Administrator,
at the same time, shall issue a notice under section 136a(c)(2)(B)
of this title for the submission of the additional data that are
required to meet such requirements.
(2) Time periods
(A) The Administrator shall take the action required by
paragraph (1)--
(i) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(B) of this section,
not later than 18 months after the date of the listing of such
active ingredient;
(ii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(C) of this section,
not later than 24 months after the date of the listing of such
active ingredient; and
(iii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(D) of this section,
not later than 33 months after the date of the listing of such
active ingredient.
(B) If the Administrator issues a notice to a registrant under
paragraph (1)(B) for the submission of additional data, the
registrant shall submit such data within a reasonable period of
time, as determined by the Administrator, but not to exceed 48
months after the issuance of such notice. The Administrator, on
application of a registrant, may extend the period prescribed by the
preceding sentence by no more than 2 years if extraordinary
circumstances beyond the control of the registrant prevent the
registrant from submitting data within such prescribed period. Upon
application of a registrant, the Administrator shall, in the case of
a minor use, extend the deadline for the production of residue
chemistry data under this subparagraph for data required solely to
support that minor use until the final deadline for submission of
data under this section for the other uses of the pesticide
established as of August 3, 1996, if--
(i) the data to support other uses of the pesticide on a
food are being provided;
(ii) the registrant, in submitting a request for such an
extension provides a schedule, including interim dates to
measure progress, to assure that the data production will be
completed before the expiration of the extension period;
(iii) the Administrator has determined that such extension
will not significantly delay the Administrator's schedule for
issuing a reregistration eligibility determination required
under this section; and
(iv) the Administrator has determined that based on existing
data, such extension would not significantly increase the risk
of any unreasonable adverse effect on the environment. If the
Administrator grants an extension under this subparagraph, the
Administrator shall monitor the development of the data and
shall ensure that the registrant is meeting the schedule for the
production of the data. If the Administrator determines that the
registrant is not meeting or has not met the schedule for the
production of such data, the Administrator may proceed in
accordance with clause (iv) of section 136a(c)(2)(B) of this
title or other provisions of this section, as appropriate,
regarding the continued registration of the affected products
with the minor use and shall inform the public of such action.
Notwithstanding the provisions of this subparagraph, the
Administrator may take action to modify or revoke the extension
under this subparagraph if the Administrator determines that the
extension for the minor use may cause an unreasonable adverse
effect on the environment. In such circumstance, the
Administrator shall provide written notice to the registrant
revoking the extension of time for submission of data. Such data
shall instead be due in accordance with the date then
established by the Administrator for submission of the data.
(3) Suspensions and penalties
The Administrator shall issue a notice of intent to suspend the
registration of a pesticide in accordance with the procedures
prescribed by section 136a(c)(2)(B)(iv) of this title if the
Administrator determines that (A) tests necessary to fill an
outstanding data requirement for such pesticide have not been
initiated within 1 year after the issuance of a notice under
paragraph (1)(B), or (B) progress is insufficient to ensure
submission of the data referred to in clause (A) within the time
period prescribed by paragraph (2)(B) or the required data have not
been submitted to the Administrator within such time period. If the
registrant does not commit to support a specific minor use of the
pesticide, but is supporting and providing data in a timely and
adequate fashion to support uses of the pesticide on a food, or if
all uses of the pesticide are nonfood uses and the registrant does
not commit to support a specific minor use of the pesticide but is
supporting and providing data in a timely and adequate fashion to
support other nonfood uses of the pesticide, the Administrator, at
the written request of the registrant, shall not take any action
pursuant to this paragraph in regard to such unsupported minor use
until the final deadline established as of August 3, 1996, for the
submission of data under this section for the supported uses
identified pursuant to this paragraph unless the Administrator
determines that the absence of the data is significant enough to
cause human health or environmental concerns. On such a
determination the Administrator may refuse the request for extension
by the registrant. Upon receipt of the request from the registrant,
the Administrator shall publish in the Federal Register a notice of
the receipt of the request and the effective date upon which the
uses not being supported will be voluntarily deleted from the
registration pursuant to section 136d(f)(1) of this title. If the
Administrator grants an extension under this paragraph, the
Administrator shall monitor the development of the data for the uses
being supported and shall ensure that the registrant is meeting the
schedule for the production of such data. If the Administrator
determines that the registrant is not meeting or has not met the
schedule for the production of such data, the Administrator may
proceed in accordance with section 136a(c)(2)(B)(iv) of this title
regarding the continued registration of the affected products with
the minor and other uses and shall inform the public of such action
in accordance with section 136d(f)(2) of this title. Notwithstanding
this subparagraph, the Administrator may deny, modify, or revoke the
temporary extension under this paragraph if the Administrator
determines that the continuation of the minor use may cause an
unreasonable adverse effect on the environment. In the event of
modification or revocation, the Administrator shall provide, in
writing, to the registrant a notice revoking the temporary extension
and establish a new effective date by which the minor use shall be
deleted from the registration.
(g) Phase five
(1) Data review
The Administrator shall conduct a thorough examination of all
data submitted under this section concerning an active ingredient
listed under subsection (c)(2) of this section and of all other
available data found by the Administrator to be relevant.
(2) Reregistration and other actions
(A) Within 1 year after the submission of all data concerning an
active ingredient of a pesticide under subsection (f) of this
section, the Administrator shall determine whether pesticides
containing such active ingredient are eligible for reregistration.
For extraordinary circumstances, the Administrator may extend such
period for not more than 1 additional year.
(B) Before reregistering a pesticide, the Administrator shall
obtain any needed product-specific data regarding the pesticide by
use of section 136a(c)(2)(B) of this title and shall review such
data within 90 days after its submission. The Administrator shall
require that data under this subparagraph be submitted to the
Administrator not later than 8 months after a determination of
eligibility under subparagraph (A) has been made for each active
ingredient of the pesticide, unless the Administrator determines
that a longer period is required for the generation of the data.
(C) After conducting the review required by paragraph (1) for
each active ingredient of a pesticide and the review required by
subparagraph (B) of this paragraph, the Administrator shall
determine whether to reregister a pesticide by determining whether
such pesticide meets the requirements of section 136a(c)(5) of this
title. If the Administrator determines that a pesticide is eligible
to be reregistered, the Administrator shall reregister such
pesticide within 6 months after the submission of the data
concerning such pesticide under subparagraph (B).
(D) If after conducting a review under paragraph (1) or
subparagraph (B) of this paragraph the Administrator determines that
a pesticide should not be reregistered, the Administrator shall take
appropriate regulatory action.
(E) As soon as the Administrator has sufficient information with
respect to the dietary risk of a particular active ingredient, but
in any event no later than the time the Administrator makes a
determination under subparagraph (C) or (D) with respect to
pesticides containing a particular active ingredient, the
Administrator shall--
(i) reassess each associated tolerance and exemption from
the requirement for a tolerance issued under section 408 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a);
(ii) determine whether such tolerance or exemption meets the
requirements of that Act [21 U.S.C. 301 et seq.];
(iii) determine whether additional tolerances or exemptions
should be issued;
(iv) publish in the Federal Register a notice setting forth
the determinations made under this subparagraph; and
(v) commence promptly such proceedings under this subchapter
and section 408 of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 346a] as are warranted by such determinations.
(h) Compensation of data submitter
If data that are submitted by a registrant under subsection (d),
(e), (f), or (g) of this section are used to support the application of
another person under section 136a of this title, the registrant who
submitted such data shall be entitled to compensation for the use of
such data as prescribed by section 136a(c)(1)(D) \2\ of this title. In
determining the amount of such compensation, the fees paid by the
registrant under this section shall be taken into account.
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\2\ See References in Text note below.
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(i) Fees
(1) Initial fee for food or feed use pesticide active
ingredients
The registrants of pesticides that contain an active ingredient
that is listed under subparagraph (B), (C), or (D) of subsection
(c)(2) of this section and that is an active ingredient of any
pesticide registered for a major food or feed use shall collectively
pay a fee of $50,000 on submission of information under paragraphs
(2) and (3) of subsection (d) of this section for such ingredient.
(2) Final fee for food or feed use pesticide active
ingredients
(A) The registrants of pesticides that contain an active
ingredient that is listed under subparagraph (B), (C), or (D) of
subsection (c)(2) of this section and that is an active ingredient
of any pesticide registered for a major food or feed use shall
collectively pay a fee of $100,000--
(i) on submission of information for such ingredient under
subsection (e)(1) of this section if data are reformatted under
subsection (e)(1)(C) of this section; or
(ii) on submission of data for such ingredient under
subsection (e)(2)(B) of this section if data are not reformatted
under subsection (e)(1)(C) of this section.
(B) The registrants of pesticides that contain an active
ingredient that is listed under subsection (c)(2)(A) of this section
and that is an active ingredient of any pesticide registered for a
major food or feed use shall collectively pay a fee of $150,000 at
such time as the Administrator shall prescribe.
(3) Fees for other pesticide active ingredients
(A) The registrants of pesticides that contain an active
ingredient that is listed under subparagraph (B), (C), or (D) of
subsection (c)(2) of this section and that is not an active
ingredient of any pesticide registered for a major food or feed use
shall collectively pay fees in amounts determined by the
Administrator. Such fees may not be less than one-half of, nor
greater than, the fees required by paragraphs (1) and (2). A
registrant shall pay such fees at the times corresponding to the
times fees prescribed by paragraphs (1) and (2) are to be paid.
(B) The registrants of pesticides that contain an active
ingredient that is listed under subsection (c)(2)(A) of this section
and that is not an active ingredient of any pesticide that is
registered for a major food or feed use shall collectively pay a fee
of not more than $100,000 and not less than $50,000 at such time as
the Administrator shall prescribe.
(4) Reduction or waiver of fees for minor use and other
pesticides
(A) An active ingredient that is contained only in pesticides
that are registered solely for agricultural or nonagricultural minor
uses, or a pesticide the value or volume of use of which is small,
shall be exempt from the fees prescribed by paragraph (3).
(B) The Administrator shall exempt any public health pesticide
from the payment of the fee prescribed under paragraph (3) if, in
consultation with the Secretary of Health and Human Services, the
Administrator determines, based on information supplied by the
registrant, that the economic return to the registrant from sales of
the pesticide does not support the registration or reregistration of
the pesticide.
(C) An antimicrobial active ingredient, the production level of
which does not exceed 1,000,000 pounds per year, shall be exempt
from the fees prescribed by paragraph (3). For purposes of this
subparagraph, the term ``antimicrobial active ingredient'' means any
active ingredient that is contained only in pesticides that are not
registered for any food or feed use and that are--
(i) sanitizers intended to reduce the number of living
bacteria or viable virus particles on inanimate surface or in
water or air;
(ii) bacteriostats intended to inhibit the growth of
bacteria in the presence of moisture;
(iii) disinfectants intended to destroy or irreversibly
inactivate bacteria, fungi, or viruses on surfaces or inanimate
objects;
(iv) sterilizers intended to destroy viruses and all living
bacteria, fungi, and their spores on inanimate surfaces; or
(v) fungicides or fungistats.
(D)(i) Notwithstanding any other provision of this subsection,
in the case of a small business registrant of a pesticide, the
registrant shall pay a fee for the reregistration of each active
ingredient of the pesticide that does not exceed an amount
determined in accordance with this subparagraph.
(ii) If during the 3-year period prior to reregistration the
average annual gross revenue of the registrant from pesticides
containing such active ingredient is--
(I) less than $5,000,000, the registrant shall pay 0.5
percent of such revenue;
(II) $5,000,000 or more but less than $10,000,000, the
registrant shall pay 1 percent of such revenue; or
(III) $10,000,000 or more, the registrant shall pay 1.5
percent of such revenue, but not more than $150,000.
(iii) For the purpose of this subparagraph, a small business
registrant is a corporation, partnership, or unincorporated business
that--
(I) has 150 or fewer employees; and
(II) during the 3-year period prior to reregistration, had
an average annual gross revenue from chemicals that did not
exceed $40,000,000.
(5) Maintenance fee
(A) Subject to other provisions of this paragraph, each
registrant of a pesticide shall pay an annual fee by January 15 of
each year of--
(i) $650 for the first registration; and
(ii) $1,300 for each additional registration, except that no
fee shall be charged for more than 200 registrations held by any
registrant.
(B) In the case of a pesticide that is registered for a minor
agricultural use, the Administrator may reduce or waive the payment
of the fee imposed under this paragraph if the Administrator
determines that the fee would significantly reduce the availability
of the pesticide for the use.
(C)(i) The amount of each fee prescribed under subparagraph (A)
shall be adjusted by the Administrator to a level that will result
in the collection under this paragraph of, to the extent
practicable, an aggregate amount of $17,000,000 fiscal year 2002.\3\
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\3\ So in original.
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(ii) in each of the fiscal years 1998, 1999, and 2000, the
Administrator is authorized to collect up to an additional
$2,000,000 in a manner consistent with subsection (k)(5) of this
section and the recommendations of the Inspector General of the
Environmental Protection Agency. The total fees that may be
collected under this clause shall not exceed $6,000,000.
(D) The maximum annual fee payable under this paragraph by--
(i) a registrant holding not more than 50 pesticide
registrations shall be $55,000; and
(ii) a registrant holding over 50 registrations shall be
$95,000.
(E)(i) For a small business, the maximum annual fee payable
under this paragraph by--
(I) a registrant holding not more than 50 pesticide
registrations shall be $38,500; and
(II) a registrant holding over 50 pesticide registrations
shall be $66,500.
(ii) For purposes of clause (i), the term ``small business''
means a corporation, partnership, or unincorporated business that--
(I) has 150 or fewer employees; and
(II) during the 3-year period prior to the most recent
maintenance fee billing cycle, had an average annual gross
revenue from chemicals that did not exceed $40,000,000.
(F) The Administrator shall exempt any public health pesticide
from the payment of the fee prescribed under paragraph (3) if, in
consultation with the Secretary of Health and Humans \4\ Services,
the Administrator determines, based on information supplied by the
registrant, that the economic return to the registrant from sales of
the pesticide does not support the registration or reregistration of
the pesticide.
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\4\ So in original. Probably should be ``Human''.
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(G) If any fee prescribed by this paragraph with respect to the
registration of a pesticide is not paid by a registrant by the time
prescribed, the Administrator, by order and without hearing, may
cancel the registration.
(H) The authority provided under this paragraph shall terminate
on September 30, 2002.
(6) Other fees
During the period beginning on October 25, 1988, and ending on
September 30, 2002, the Administrator may not levy any other fees
for the registration of a pesticide under this subchapter except as
provided in paragraphs (1) through (5).
(7) Apportionment
(A) If two or more registrants are required to pay any fee
prescribed by paragraph (1), (2), or (3) with respect to a
particular active ingredient, the fees for such active ingredient
shall be apportioned among such registrants on the basis of the
market share in United States sales of the active ingredient for the
3 calendar years preceding the date of payment of such fee, except
that--
(i) small business registrants that produce the active
ingredient shall pay fees in accordance with paragraph (4)(C);
and
(ii) registrants who have no market share but who choose to
reregister a pesticide containing such active ingredient shall
pay the lesser of--
(I) 15 percent of the reregistration fee; or
(II) a proportionate amount of such fee based on the
lowest percentage market share held by any registrant active
in the marketplace.
In no event shall registrants who have no market share but who
choose to reregister a pesticide containing such active
ingredient collectively pay more than 25 percent of the total
active ingredient reregistration fee.
(B) The Administrator, by order, may require any registrant to
submit such reports as the Administrator determines to be necessary
to allow the Administrator to determine and apportion fees under
this subsection, to determine the registrant's eligibility for a
reduction or waiver of a fee, or to determine the volume usage for
public health pesticides.
(C) If any such report is not submitted by a registrant after
receiving notice of such report requirement, or if any fee
prescribed by this subsection (other than paragraph (5)) for an
active ingredient is not paid by a registrant to the Administrator
by the time prescribed under this subsection, the Administrator, by
order and without hearing, may cancel each registration held by such
registrant of a pesticide containing the active ingredient with
respect to which the fee is imposed. The Administrator shall
reapportion the fee among the remaining registrants and notify the
registrants that the registrants are required to pay to the
Administrator any unpaid balance of the fee within 30 days after
receipt of such notice.
(j) Exemption of certain registrants
The requirements of subsections (d), (e), (f), and (i) of this
section (other than subsection (i)(5) of this section) regarding data
concerning an active ingredient and fees for review of such data shall
not apply to any person who is the registrant of a pesticide to the
extent that, under section 136a(c)(2)(D) of this title, the person would
not be required to submit or cite such data to obtain an initial
registration of such pesticide.
(k) Reregistration and expedited processing fund
(1) Establishment
There shall be established in the Treasury of the United States
a reregistration and expedited processing fund which shall be known
as the Reregistration and Expedited Processing Fund.
(2) Source and use
(A) All moneys derived from fees collected by the Administrator
under subsection (i) of this section shall be deposited in the fund
and shall be available to the Administrator, without fiscal year
limitation, specifically to offset the costs of reregistration and
expedited processing of the applications specified in paragraph (3).
Such moneys derived from fees may not be expended in any fiscal year
to the extent such moneys derived from fees would exceed money
appropriated for use by the Administrator and expended in such year
for such costs of reregistration and expedited processing of such
applications. The Administrator shall, prior to expending any such
moneys derived from fees--
(i) effective October 1, 1997, adopt specific and cost
accounting rules and procedures as approved by the General
Accounting Office and the Inspector General of the Environmental
Protection Agency to ensure that moneys derived from fees are
allocated solely to the costs of reregistration and expedited
processing of the applications specified in paragraph (3) in the
same portion as appropriated funds;
(ii) prohibit the use of such moneys derived from fees to
pay for any costs other than those necessary to achieve
reregistration and expedited processing of the applications
specified in paragraph (3); and
(iii) ensure that personnel and facility costs associated
with the functions to be carried out under this paragraph do not
exceed agency averages for comparable personnel and facility
costs.
(B) The Administrator shall also--
(i) complete the review of unreviewed reregistration studies
required to support the reregistration eligibility decisions
scheduled for completion in accordance with subsection (l)(2) of
this section; and
(ii) contract for such outside assistance as may be
necessary for review of required studies, using a generally
accepted competitive process for the selection of vendors of
such assistance.
(3) Expedited processing of similar applications
(A) The Administrator shall use for each of the fiscal years
1997 through 2002, not more than \1/10\ of the maintenance fees
collected in such fiscal year to obtain sufficient personnel and
resources to assure the expedited processing and review of any
application that--
(i) proposes the initial or amended registration of an end-
use pesticide that, if registered as proposed, would be
identical or substantially similar in composition and labeling
to a currently-registered pesticide identified in the
application, or that would differ in composition and labeling
from any such currently-registered pesticide only in ways that
would not significantly increase the risk of unreasonable
adverse effects on the environment;
(ii) proposes an amendment to the registration of a
registered pesticide that does not require scientific review of
data; or
(iii) proposes the initial or amended registration of an end
use pesticide that, if registered as proposed, would be used for
a public health pesticide.
(B) Any amounts made available under subparagraph (A) shall be
used to obtain sufficient personnel and resources to carry out the
activities described in such subparagraph that are in addition to
the personnel and resources available to carry out such activities
on October 25, 1988.
(C) So long as the Administrator has not met the time frames
specified in clause (ii) of section 136a(c)(3)(B) of this title with
respect to any application subject to section 136a(c)(3)(B) of this
title that was received prior to August 3, 1996, the Administrator
shall use the full amount of the fees specified in subparagraph (A)
for the purposes specified therein. Once all applications subject to
section 136a(c)(3)(B) of this title that were received prior to
August 3, 1996, have been acted upon, no limitation shall be imposed
by the preceding sentence of this subparagraph so long as the
Administrator meets the time frames specified in clause (ii) of
section 136a(c)(3)(B) of this title on 90 percent of affected
applications in a fiscal year. Should the Administrator not meet
such time frames in a fiscal year, the limitations imposed by the
first sentence of this subparagraph shall apply until all overdue
applications subject to section 136a(c)(3)(B) of this title have
been acted upon.
(4) Unused funds
Money in the fund not currently needed to carry out this section
shall be--
(A) maintained on hand or on deposit;
(B) invested in obligations of the United States or
guaranteed thereby; or
(C) invested in obligations, participations, or other
instruments that are lawful investments for fiduciary, trust, or
public funds.
(5) Accounting and performance
The Administrator shall take all steps necessary to ensure that
expenditures from fees authorized by subsection (i)(5)(C)(ii) of
this section are used only to carry out the goals established under
subsection (l) of this section. The Reregistration and Expedited
Processing Fund shall be designated as an Environmental Protection
Agency component for purposes of section 3515(c) of title 31. The
annual audit required under section 3521 of such title of the
financial statements of activities under this subchapter under
section 3515(b) of such title shall include an audit of the fees
collected under subsection (i)(5)(C) of this section and disbursed,
of the amount appropriated to match such fees, and of the
Administrator's attainment of performance measures and goals
established under subsection (l) of this section. Such an audit
shall also include a review of the reasonableness of the overhead
allocation and adequacy of disclosures of direct and indirect costs
associated with carrying out the reregistration and expedited
processing of the applications specified in paragraph (3), and the
basis for and accuracy of all costs paid with moneys derived from
such fees. The Inspector General shall conduct the annual audit and
report the findings and recommendations of such audit to the
Administrator and to the Committees on Agriculture of the House of
Representatives and the Senate. The cost of such audit shall be paid
for out of the fees collected under subsection (i)(5)(C) of this
section.
(l) Performance measures and goals
The Administrator shall establish and publish annually in the
Federal Register performance measures and goals. Such measures and goals
shall include--
(1) the number of products reregistered, canceled, or amended,
the status of reregistration, the number and type of data requests
under section 136a(c)(2)(B) of this title issued to support product
reregistration by active ingredient, the progress in reducing the
number of unreviewed, required reregistration studies, the aggregate
status of tolerances reassessed, and the number of applications for
registration submitted under subsection (k)(3) of this section that
were approved or disapproved;
(2) the future schedule for reregistrations, including the
projection for such schedules that will be issued under subsection
(g)(2)(A) and (B) of this section in the current fiscal year and the
succeeding fiscal year; and
(3) the projected year of completion of the reregistrations
under this section.
(m) Judicial review
Any failure of the Administrator to take any action required by this
section shall be subject to judicial review under the procedures
prescribed by section 136n(b) of this title.
(n) Authorization of funds to develop public health data
(1) ``Secretary'' defined
For the purposes of this section, ``Secretary'' means the
Secretary of Health and Human Services, acting through the Public
Health Service.
(2) Consultation
In the case of a pesticide registered for use in public health
programs for vector control or for other uses the Administrator
determines to be human health protection uses, the Administrator
shall, upon timely request by the registrant or any other interested
person, or on the Administrator's own initiative may, consult with
the Secretary prior to taking final action to suspend registration
under section 136a(c)(2)(B)(iv) of this title, or cancel a
registration under section 136a-1, 136d(e), or 136d(f) of this
title. In consultation with the Secretary, the Administrator shall
prescribe the form and content of requests under this section.
(3) Benefits to support family
The Administrator, after consulting with the Secretary, shall
make a determination whether the potential benefits of continued use
of the pesticide for public health or health protection purposes are
of such significance as to warrant a commitment by the Secretary to
conduct or to arrange for the conduct of the studies required by the
Administrator to support continued registration under section 136a
of this title or reregistration under this section.
(4) Additional time
If the Administrator determines that such a commitment is
warranted and in the public interest, the Administrator shall notify
the Secretary and shall, to the extent necessary, amend a notice
issued under section 136a(c)(2)(B) of this title to specify
additional reasonable time periods for submission of the data.
(5) Arrangements
The Secretary shall make such arrangements for the conduct of
required studies as the Secretary finds necessary and appropriate to
permit submission of data in accordance with the time periods
prescribed by the Administrator. Such arrangements may include
Public Health Service intramural research activities, grants,
contracts, or cooperative agreements with academic, public health,
or other organizations qualified by experience and training to
conduct such studies.
(6) Support
The Secretary may provide for support of the required studies
using funds authorized to be appropriated under this section, the
Public Health Service Act [42 U.S.C. 201 et seq.], or other
appropriate authorities. After a determination is made under
subsection (d) of this section, the Secretary shall notify the
Committees on Appropriations of the House of Representatives and the
Senate of the sums required to conduct the necessary studies.
(7) Authorization of appropriations
There is authorized to be appropriated to carry out the purposes
of this section $12,000,000 for fiscal year 1997, and such sums as
may be necessary for succeeding fiscal years.
(June 25, 1947, ch. 125, Sec. 4, formerly Sec. 3A, as added and
renumbered Sec. 4, Pub. L. 100-532, title I, Sec. 102(a), title VIII,
Sec. 801(q)(2)(A), Oct. 25, 1988, 102 Stat. 2655, 2683; amended Pub. L.
101-624, title XIV, Sec. 1493, Nov. 28, 1990, 104 Stat. 3628; Pub. L.
102-237, title X, Sec. 1006(a)(4), (e), (f), Dec. 13, 1991, 105 Stat.
1895-1897; Pub. L. 104-170, title I, Sec. 103, title II,
Secs. 210(c)(2), (f)(1), 232, 237, title V, Sec. 501, Aug. 3, 1996, 110
Stat. 1490, 1496, 1498, 1508, 1509, 1536; Pub. L. 107-73, title III,
Nov. 26, 2001, 115 Stat. 686.)
References in Text
The effective date of this section, referred to in subsecs. (a),
(c)(1), (2), and (e)(4)(A), is 60 days after Oct. 25, 1988. See
Effective Date note below.
Section 136a(c)(1)(D) of this title, referred to in subsecs.
(e)(1)(I) and (h), was redesignated section 136a(c)(1)(F) of this title
by Pub. L. 102-237, title X, Sec. 1006(a)(3)(B), Dec. 13, 1991, 105
Stat. 1894.
The Federal Food, Drug, and Cosmetic Act, referred to in subsec.
(g)(2)(E)(ii), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,
which is classified generally to chapter 9 (Sec. 301 et seq.) of Title
21, Food and Drugs. For complete classification of this Act to the Code,
see section 301 of Title 21 and Tables.
The Public Health Service Act, referred to in subsec. (n)(6), is act
July 1, 1944, ch. 373, 58 Stat. 682, as amended, which is classified
generally to chapter 6A (Sec. 201 et seq.) of Title 42, The Public
Health and Welfare. For complete classification of this Act to the Code,
see Short Title note set out under section 201 of Title 42 and Tables.
Prior Provisions
A prior section 4 of act June 25, 1947, which was classified to
section 136b of this title was transferred to section 11(a)-(c) of act
June 25, 1947, which is classified to section 136i(a)-(c) of this title.
Another prior section 4 of act June 25, 1947, was classified to
section 135b of this title prior to amendment of act June 25, 1947, by
Pub. L. 92-516.
Amendments
2001--Pub. L. 107-73, which directed the amendment of section 136a-1
of title 7, U.S.C., was executed by making the amendments to this
section, which is section 4 of the Federal Insecticide, Fungicide, and
Rodenticide Act, to reflect the probable intent of Congress. See below.
Subsec. (i)(5)(C)(i). Pub. L. 107-73 substituted ``$17,000,000'' for
``$14,000,000'' and ``fiscal year 2002'' for ``each fiscal year''.
Subsec. (i)(5)(H). Pub. L. 107-73 substituted ``2002'' for ``2001''.
Subsec. (i)(6). Pub. L. 107-73 substituted ``2002'' for ``2001''.
Subsec. (k)(3)(A). Pub. L. 107-73 substituted ``2002'' for ``2001''
and ``\1/10\'' for ``\1/7\'' in introductory provisions.
1996--Pub. L. 104-170, Sec. 501, which directed amendment of section
4 without specifying the name of the Act being amended, was executed to
this section, which is section 4 of the Federal Insecticide, Fungicide,
and Rodenticide Act, to reflect the probable intent of Congress.
Subsec. (d)(4)(B). Pub. L. 104-170, Sec. 210(c)(2), inserted at end
provisions authorizing extension of deadline for production of residue
chemistry data in case of minor use and setting forth conditions to be
met for such extension in cls. (i) to (iv).
Subsec. (d)(6). Pub. L. 104-170, Sec. 210(f)(1)(A), inserted at end
provisions delaying upon written request action with regard to
unsupported minor uses, authorizing refusal of request where there are
health or environmental concerns, authorizing publication of notice in
Federal Register and monitoring of development of data, setting forth
procedures where registrant is not meeting or has not met schedule for
production of data, and authorizing denial, modification, or revocation
of temporary extension where use may cause adverse effect on environment
and requiring notice of such revocation to registrant.
Subsec. (e)(2)(B). Pub. L. 104-170, Sec. 210(c)(2), inserted at end
provisions authorizing extension of deadline for production of residue
chemistry data in case of minor use and setting forth conditions to be
met for such extension in cls. (i) to (iv).
Subsec. (e)(3)(A). Pub. L. 104-170, Sec. 210(f)(1)(B), inserted at
end provisions delaying upon written request action with regard to
unsupported minor uses, authorizing refusal of request where there are
health or environmental concerns, authorizing publication of notice in
Federal Register and monitoring of development of data, setting forth
procedures where registrant is not meeting or has not met schedule for
production of data, and authorizing denial, modification, or revocation
of temporary extension where use may cause adverse effect on environment
and requiring notice of such revocation to registrant.
Subsec. (f)(2)(B). Pub. L. 104-170, Sec. 210(c)(2), inserted at end
provisions authorizing extension of deadline for production of residue
chemistry data in case of minor use and setting forth conditions to be
met for such extension in cls. (i) to (iv).
Subsec. (f)(3). Pub. L. 104-170, Sec. 210(f)(1)(A), inserted at end
provisions delaying upon written request action with regard to
unsupported minor uses, authorizing refusal of request where there are
health or environmental concerns, authorizing publication of notice in
Federal Register and monitoring of development of data, setting forth
procedures where registrant is not meeting or has not met schedule for
production of data, and authorizing denial, modification, or revocation
of temporary extension where use may cause adverse effect on environment
and requiring notice of such revocation to registrant.
Subsec. (g)(2)(E). Pub. L. 104-170, Sec. 103, added subpar. (E).
Subsec. (i)(4)(B) to (D). Pub. L. 104-170, Sec. 232(1), added
subpar. (B) and redesignated former subpars. (B) and (C) as (C) and (D),
respectively.
Subsec. (i)(5)(C). Pub. L. 104-170, Sec. 501(a)(2), designated
existing provisions as cl. (i) and added cl. (ii).
Subsec. (i)(5)(F), (G). Pub. L. 104-170, Sec. 232(2), added subpar.
(F) and redesignated former subpar. (F) as (G).
Subsec. (i)(5)(H). Pub. L. 104-170, Sec. 501(a)(1), substituted
``2001'' for ``1997''.
Pub. L. 104-170, Sec. 232(2), redesignated subpar. (G) as (H).
Subsec. (i)(6). Pub. L. 104-170, Sec. 501(a)(1), substituted
``2001'' for ``1997''.
Subsec. (i)(7)(B). Pub. L. 104-170, Sec. 232(3), substituted ``, to
determine the registrant's eligibility'' for ``or to determine the
registrant's eligibility'' and inserted before period at end ``, or to
determine the volume usage for public health pesticides''.
Subsec. (k)(1). Pub. L. 104-170, Sec. 501(b), inserted ``which shall
be known as the Reregistration and Expedited Processing Fund'' before
period at end.
Subsec. (k)(2). Pub. L. 104-170, Sec. 501(c), amended heading and
text of par. (2) generally. Prior to amendment, text read as follows:
``All fees collected by the Administrator under subsection (i) of this
section shall be deposited into the fund and shall be available to the
Administrator, without fiscal year limitation, to carry out
reregistration and expedited processing of similar applications.''
Subsec. (k)(3)(A). Pub. L. 104-170, Sec. 501(d)(1), which directed
the amendment of introductory provisions by substituting ``for each of
the fiscal years 1997 through 2001, not more than \1/7\ of the
maintenance fees collected in such fiscal year'' for ``for each of the
fiscal years 1992, 1993, and 1994, \1/7\th of the maintenance fees
collected, up to 2 million each year'', was executed by making the
substitution for text which contained the phrase ``$2 million'', to
reflect the probable intent of Congress.
Subsec. (k)(3)(A)(iii). Pub. L. 104-170, Sec. 232(4), added cl.
(iii).
Subsec. (k)(3)(C). Pub. L. 104-170, Sec. 501(d)(2), added subpar.
(C).
Subsec. (k)(5). Pub. L. 104-170, Sec. 501(e), amended heading and
text of par. (5) generally. Prior to amendment, text read as follows:
``The Administrator shall--
``(A) provide an annual accounting of the fees collected and
disbursed from the fund; and
``(B) take all steps necessary to ensure that expenditures from
such fund are used only to carry out this section.''
Subsec. (l). Pub. L. 104-170, Sec. 501(f), added subsec. (l). Former
subsec. (l) redesignated (m).
Subsec. (m). Pub. L. 104-170, Sec. 501(f), redesignated subsec. (l)
as (m). Former subsec. (m) redesignated (n).
Pub. L. 104-170, Sec. 237, added subsec. (m).
Subsec. (n). Pub. L. 104-170, Sec. 501(f), redesignated subsec. (m)
as (n).
1991--Subsec. (f)(3). Pub. L. 102-237, Sec. 1006(a)(4), realigned
margin.
Subsec. (i)(5). Pub. L. 102-237, Sec. 1006(e), amended par. (5)
generally, substituting, in subpar. (A), provisions relating to January
15 for provisions relating to March 1, in subpar. (A)(i), provisions
relating to fee of $650 for first registration for provisions relating
to fee of $425 for each registration for registrants holding not more
than 50 registrations, and in subpar. (A)(ii), provisions relating to
fee of $1,300 for each additional registration up to 200 registrations,
with no fee thereafter, for provisions relating to fee of $425 for each
registration up to 50, $100 for each registration over 50, with no fee
after 200 registrations, redesignating provisions formerly set out in
subpar. (A), following cl. (ii), as subpar. (B), and substituting
provisions relating to fee under this par. for provisions relating to
fee under this subpar., redesignating former subpar. (B) as (C),
striking former subpar. (C), which set maximum annual fee for
registrants under subpar. (A)(i) at $20,000, and for registrants under
subpar. (A)(ii) at $35,000, adding subpars. (D) and (E), and
redesignating former subpars. (D) and (E) as (F) and (G), respectively.
Subsec. (k)(3)(A). Pub. L. 102-237, Sec. 1006(f), substituted ``for
each of the fiscal years 1992, 1993, and 1994, \1/7\th of the
maintenance fees collected, up to $2 million each year'' for ``each
fiscal year not more than $2,000,000 of the amounts in the fund''.
1990--Subsec. (i)(5)(A). Pub. L. 101-624 inserted sentence at end
relating to reduction or waiver of fee where pesticide is registered for
minor agricultural use.
Effective Date
Section effective on expiration of 60 days after Oct. 25, 1988, see
section 901 of Pub. L. 100-532, set out as an Effective Date of 1988
Amendment note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136a, 136d, 136j of this
title; title 21 section 346a.
